FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations
    Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.

  • The Global CDMO Model: Value Creation Is Not Just A Matter Of Integrating The Pieces
    The Global CDMO Model: Value Creation Is Not Just A Matter Of Integrating The Pieces

    I recently talked to a good friend who sold his company, a midsize service provider, to a much larger global end-to-end CDMO. His experience was not atypical of the trend that has been going on for the better part of the past decade. Namely, that the industry is consolidating, moving to a more strategic outsourcing relationship where end-to-end service offerings seem to dominate over the traditional focused-service model.

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques
    Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

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PHARMA OUTSOURCING WHITE PAPERS

Scalable Strategies For Parenteral Dosage Form Selection Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

 

Multiplexing: Managing Risk With Proven, Single-Use Solutions Multiplexing: Managing Risk With Proven, Single-Use Solutions

With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

Liquid Filled And Sealed Hard Gelatin Capsules
White Paper: Liquid Filled And Sealed Hard Gelatin Capsules
On Target With Antibody Drug Conjugates

Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

Pharma Production Technology Transfers: Reaping Rewards, Reducing Risks

Transferring production – and the technologies that undergird it – can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

5 Steps To Optimizing Cost And Performance In Temperature-Controlled Pharmaceutical Shipments

Important things come in packages of all sizes, especially in the world of temperature-controlled, pharmaceutical transport, where it is not uncommon for even the smallest shipment to have a far-reaching impact on researchers, manufacturers, healthcare providers and patients.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Optimizing Elution Conditions On Capto MMC Using Design Of Experiments

The multimodal ligand of Capto™ MMC generally requires elution conditions that diff er from those used with traditional ion exchangers. This application note describes how Design of Experiments (DoE) can be used to optimize elution conditions and thus recovery of a target protein

Polishing Of Monoclonal Antibodies Using Capto™ S ImpAct

Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules.

Engineering Characterization Of The Single-Use Xcellerex XDR-2000 Stirred-Tank Bioreactor System

This application note describes the physical characteristics of the XDR-2000 bioreactor system suitable for use in mammalian cell culture applications. 

Expediting A Promising New Therapy

An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease.

More Pharma Outsourcing App Notes & Case Studies

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Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown January 25, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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